Application 202396
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LANSOPRAZOLE | LANSOPRAZOLE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 15MG | No | No |
| 002 | LANSOPRAZOLE | LANSOPRAZOLE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 30MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-6981 | Lansoprazole | lansoprazole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6981 | Lansoprazole | lansoprazole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6981 | Lansoprazole | lansoprazole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6982 | Lansoprazole | lansoprazole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6982 | Lansoprazole | lansoprazole | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6982 | Lansoprazole | lansoprazole | Mylan Pharmaceuticals Inc. | ANDA | Current |